Cytology sampling system and method of utilizing the same

ABSTRACT

A cytology sampling system includes a catheter tube and a cytology tool. The catheter tube has open proximal and distal ends. The cytology tool is insertable through the catheter tube and includes a flexible shaft, a brush, and a position sensor. The flexible shaft defines proximal and distal ends thereof. The brush is coupled to the distal end of the flexible shaft. The brush includes a plurality of brush shafts. Each brush shaft has bristles disposed along a portion of a length thereof. The bristles are coupled to and extend radially away from an outer surface of each of the brush shafts. The bristles are configured to collect cell samples from targeted tissue of a patient. The position sensor provides an indication of the location of the position sensor within a luminal structure. The system may include a positioning assembly for placing the distal end of the catheter tube adjacent the target tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/176,256, filed Feb. 10, 2014, entitled Cytology Sampling System andMethod of Utilizing the Same, which claims the benefit of the filingdate of provisional U.S. Patent Application No. 61/763,316, filed Feb.11, 2013.

INTRODUCTION

The present disclosure relates to the collecting of cell specimens fordiagnostic purposes and, more specifically, a cytology sampling toolthat is positionable through one or more branched luminal networks of apatient for collecting cell specimens.

BACKGROUND

Cancer can be prevented, treated, and possibly cured if it is detectedearly enough, preferably in its precancerous or precursor stages.Accordingly, much effort has been directed to developing improvements inearly detection devices and of the presence of cancer in its earlystages.

Samples that contain more cells provide a greater accuracy and greaterlikelihood of early detection of the presence of cancer. A continuingneed exists for devices capable of collecting larger cell samples formtissue of a patient.

Endobronchial navigation uses CT image data to create a navigation planto facilitate advancing a navigation catheter (or other suitable device)through a bronchoscope and a branch of the bronchus of a patient to thenodule. Electromagnetic tracking may also may be utilized in conjunctionwith the CT data to facilitate guiding the navigation catheter throughthe branch of the bronchus to the nodule. In certain instances, thenavigation catheter may be positioned within one of the airways of thebranched luminal networks adjacent to or within the nodule or point ofinterest to provide access for one or more tools. Once the navigationcatheter is in position, fluoroscopy may be used to visualize cytologytools, such as, for example, biopsy brushes, needle brushes and biopsyforceps as they are passed through the navigation catheter and into thelung and to the nodule or point of interest.

SUMMARY

In an aspect of the present disclosure, a cytology tool includes aflexible shaft, a brush, and a position sensor. The flexible shaftdefines proximal and distal ends. The brush is coupled to the distal endof the flexible shaft. The brush includes a plurality of brush shaftseach having bristles along a portion of a length thereof. The bristlesare coupled to and extend radially away from an outer surface of each ofthe plurality of brush shafts. The position sensor is configured toprovide an indication of the location of the position sensor within aluminal structure. The distal ends of each of the plurality of brushshafts may be biased away from the distal ends of each of the otherbrush shafts.

In some embodiments, distal ends of each of the plurality of brushshafts include needle tips for penetrating tissue. In certainembodiments, distal ends of each of the plurality of brush shafts areblunt for atraumatically contacting tissue.

In some embodiments, the bristles are helically disposed along a lengthof each of the brush shafts. The bristles may be disposed along theentire length of each of the brush shafts.

In aspects of the present disclosure, a cytology sampling systemincludes a catheter tube and a cytology tool. The catheter tube includesopen proximal and distal ends. The cytology tool may be any of thecytology tools disclosed herein.

In some embodiments, the brush has a transport configuration such thatthe distal ends of each the plurality of brush shafts adjacent oneanother and a deployed configuration such that the distal ends of eachof the plurality of brush shafts are spaced-apart from one another. Inthe transport configuration, the brush may be disposed within thecatheter tube between the proximal and distal ends thereof and in thedeployed configuration, the brush may extend from the distal end of thecatheter tube.

In certain embodiments, the cytology sampling system includes apositioning detection system operatively coupled to the position sensorto determine the location of the position sensor with respect totargeted tissue within a bronchial airway. In particular embodiments,the cytology sampling system may include a locatable guide with asteerable distal tip and a working channel. The steerable distal tip isadapted to position the position sensor adjacent target tissue within abronchial airway.

In some aspects of the present disclosure, a method of sampling tissueincludes identifying the location of a target in a luminal structure,generating a pathway plan to the target, traversing a cytology toolthrough the luminal network while sensing its location, generating arepresentation of the cytology tool traversing the luminal network tothe target, and contacting the target tissue with bristles of thecytology tool. The cytology tool may be any of the cytology toolsdisclosed herein. The method may further include inserting the cytologytool through a catheter tube. The method may include extending thebristles of the cytology tool from a distal end of the catheter tubesuch that the brush shafts bias away from one another. Positioning thedistal end of the catheter tube may include inserting the catheter tubethrough a working channel of a positioning assembly positioned adjacentthe target.

In some embodiments, traversing the luminal network includes steering adistal end of the cytology tool to a location adjacent the target with asteerable distal tip. In certain embodiments, the method includesregistering a sensed position of the cytology tool to image data of theluminal network. The method may include registering a sensed position ofthe cytology tool to image data of the luminal network. The method mayalso include registering the sensed position of the cytology tool to a3D model of the luminal network.

In certain embodiments, the method includes confirming the placement ofthe cytology tool using one or more imaging modalities. In particularembodiments, contacting the target tissue includes penetrating the wallof a body lumen with a needle tip of at least one of the plurality ofbrush shafts to contact the target with bristles of the at least one ofthe plurality of brush shafts.

Further, to the extent consistent, any of the aspects described hereinmay be used in conjunction with any or all of the other aspectsdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith references to the drawings, wherein:

FIG. 1 is a perspective view of a cytology sampling system including acytology catheter assembly configured for use with the cytology samplingsystem in accordance with the present disclosure with the brush in atransport configuration;

FIG. 2 is a perspective view of the cytology catheter assembly of FIG. 1with the brush in a deployed configuration;

FIG. 3 is an enlarged view of the detail area 3 shown in FIG. 2;

FIG. 4 is a screen shot of a CT based luminal navigation system inaccordance with the present disclosure;

FIG. 5 is a perspective view of a cytology sampling system and luminalnavigation system configured for use the cytology catheter assemblyshown in FIG. 1 in accordance with the present disclosure;

FIG. 6 is a side view of a luminal catheter delivery assembly includingan extended working channel and locatable guide catheter in accordancewith the present disclosure;

FIG. 7 is a partial, perspective view of a distal end of the locatableguide catheter shown in FIG. 6;

FIG. 8 is a side view of the extended working channel shown in FIG. 7with the guided tip extending from a distal end thereof;

FIG. 9 is a screen shot of a CT based luminal navigation system inaccordance with the present disclosure;

FIG. 10A is a schematic, plan view of the extended working channelpositioned within a bronchoscope prior to being positioned within atrachea of a patient;

FIG. 10B is a schematic, plan view of the bronchoscope shown in FIG. 10Apositioned within the trachea of the patient with the extended workingchannel extending distally therefrom;

FIG. 10C is a partial, cutaway view of the extended working channel andlocatable guide positioned within the bronchoscope;

FIG. 11A is a schematic, plan view of the bronchoscope positioned withinthe trachea of the patient with the extended working channel extendingdistally therefrom; and

FIG. 11B is a partial, cutaway view of the extended working channel andthe cytology catheter assembly of FIG. 1 positioned within thebronchoscope.

DETAILED DESCRIPTION

A sampling tool, such as a cytology-sampling tool that is positionablethrough one or more branched luminal networks of a patient to sampletissue may prove useful in the surgical arena and the present disclosureis directed to such apparatus, systems, and methods. Access to luminalnetworks may be percutaneous or through a natural orifice. In the caseof a natural orifice, an endobronchial approach may be particularlyuseful in the treatment of lung disease or the like. Targets,navigation, access, and treatment may be planned pre-procedurally usinga combination of imaging and/or planning software. In accordance withthese aspects of the present disclosure, the planning software may offercustom guidance using pre-procedure images. Navigation of the luminalnetwork may be accomplished using image-guidance. These image-guidancesystems may be separate or integrated with the cytology sampling tool ora separate access tool and may include MRI, CT, fluoroscopy, ultrasound,electrical impedance tomography, optical, and device tracking systems.Methodologies for locating the separate or integrated to the samplingdevice or a separate access tool include EM, IR, echolocation, optical,and others. Tracking systems may be integrated into imaging device,where tracking is done in virtual space or fused with preoperative orlive images. In some cases, the sampling target may be directly accessedfrom within the lumen, such as for the sampling of the endobronchialwall for COPD, Asthma, lung cancer, etc. In other cases, the samplingtool and/or an additional access tool may be required to pierce thelumen and extend into other tissues to reach the target, such as for thesampling of disease within the parenchyma. Final localization andconfirmation of sampling tool placement may be performed with imaging ornavigational guidance using the modalities listed above. The monitoringof the sampling may be monitored from within the lumen orextracorporeally using the image-guidance modalities described above.

Detailed embodiments of the present disclosure are disclosed herein;however, the disclosed embodiments are merely examples of thedisclosure, which may be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one skilled in the art to variouslyemploy the present disclosure in virtually any appropriately detailedstructure.

Referring to FIGS. 1-3, a cytology sampling system 10 is provided inaccordance with the present disclosure including a cytology catheterassembly 12. The cytology catheter assembly 12 includes a cytology tool14 and a catheter tube 43 configured to house the cytology tool 14. Aproximal end 43 a of the catheter tube 43 is open and may include a cuff49. A distal end 43 b of the catheter tube 43 is open. The catheter tube43 may have an outer diameter in a range of about 1.5 mm to about 2.5mm, e.g., about 1.92 mm.

The cytology tool 14 includes a handle 40, a flexible shaft 42, and abrush 44. The handle 40 includes a distal handle surface 41 configuredto abut the proximal end 43 a of the catheter tube 43. A working lengthof the flexible shaft 42 distally extends from the distal handle surface41 to the brush 44 and is insertable through the catheter tube 43 asdetailed below. The working length of the flexible shaft 42 may be in arange of about 60 cm to about 180 cm, e.g., about 120 cm. The brush 44is coupled to a distal end 42 b of the flexible shaft 42. As shown inFIG. 2, brush 44 includes three brush tips 45; however, it iscontemplated that brush 44 may include a fewer or a greater number ofbrush tips 45. The inclusion of additional brush tips has been shown toincrease the number of cells collected from targeted tissue during asampling procedure.

With particular reference to FIG. 3, each brush tip 45 includes a brushshaft 46, bristles 47, and a tip 48. The brush shaft 46 is flexible andbiased away from a longitudinal axis defined by the flexible shaft 42.The bristles 47 cover a portion of the brush shaft 46. In embodiments,the bristles 47 are disposed along an entire length L of the brush shaft46. In some embodiments, the bristles 47 are helically disposed about aportion of the length L of the brush shaft 46. The bristles 47 areconfigured to capture tissue, i.e., cells, from targeted tissue. The tip48 may be a needle tip configured to penetrate tissue. In certainembodiments, the tip 48 may be blunt to atraumatically contact tissue.The brush shaft 46 defines the length L from a proximal end 46 a to adistal end 46 b thereof. The length L may be in a range of about 10 mmto about 25 mm, e.g., about 15 mm. It is also contemplated that thelength L may be less than 10 mm or greater than 25 mm. Each brush shaft46 may have an outer diameter in a range of about 0.5 mm to about 1 mm,e.g., about 0.75 mm. The bristles 47 may be constructed of nylonextending in a range of about 0.25 mm to about 1.0 mm, e.g., about 0.85mm, from the brush shaft 46.

The brush 44 has a transport or insertion configuration (FIG. 1) and adeployed configuration (FIG. 2). In the transport configuration eachbrush shaft 46 is substantially aligned with the other brush shafts 46with the distal ends 46 b of the brush shafts 46 adjacent one another asshown in FIG. 1. The brush 44 is disposed within the catheter tube 43such that catheter tube 43 urges each brush shaft 46 into substantialalignment with the longitudinal axis defined by the flexible shaft 42 tosubstantially align the brush shafts 46 in the transport configuration.In the deployed configuration, the distal ends 46 b of the brush shafts46 are spaced-apart from one another in cooperation with the biasing ofthe brush shafts 46 as shown in FIG. 2. The brush 44 is disposed outsideof the catheter tube 43 permitting the brush shafts 46 to spread-apartinto the deployed configuration.

In use, the distal end 43 b of the catheter tube 43 is positionedadjacent targeted tissue with the brush 44 in the transportconfiguration and the distal handle surface 41 of the handle 40spaced-apart from the proximal end 43 a of the catheter tube 43 as shownin FIG. 1. A method for positioning the distal end 43 b of the cathetertube 43 adjacent targeted tissue is described in detail below. When thedistal end 43 b is positioned adjacent the targeted tissue, the distalhandle surface 41 of the handle 40 is moved towards the proximal end 43a of the catheter tube 43 to extend the brush 44 from the distal end 43b of the catheter tube 43 as shown in FIG. 2. When the brush 44 extendsfrom the distal end 43 b of the catheter tube 43, the brush shafts 46bias the brush 44 to the deployed configuration. In the deployedconfiguration, the bristles 47 contact targeted tissue to capturing cellsamples from the targeted tissue. When the bristles 47 have capturedcell samples, the distal handle surface 41 of the handle 40 is retractedaway from the proximal end 43 a of the catheter tube 43 to withdraw thebrush 44 into the distal end 43 b of the catheter tube 43 transitioningthe brush 44 into the transport configuration. The cell samples areretained on the bristles 47 of the brush 44 when the brush 44 iswithdrawn into the catheter tube 43. The cell samples may be removedfrom the bristles 47 and examined to determine if the targeted tissue isdiseased. It is also contemplated that the catheter tube 43 may be usedto aspirate cells adjacent the distal end thereof to retain cellsamples.

In embodiments, that the bristles 47 capture tissue between the brushshafts 46 as the brush 44 transitions from the deployed configuration tothe transport configuration. For example, the distal ends 46 b of thebrush shafts 46 may pierce targeted tissue and the catheter tube 43 maybe advanced over the brush 44 to transition the brush 44 to thetransport configuration such that a portion of the tissue between thebrush shafts 46 (i.e., the tissue pierced by the brush shafts 46) isretained between the brush shafts 46 and drawn into the catheter tube43.

The cytology catheter assembly 12, depicted in FIG. 1 is configured tocollect cell samples from targeted tissue, and as further set forth inFIG. 4 enables a method of identifying targeted tissue (hereinaftersimply referred to as “a target”) utilizing computed tomographic (CT)images, and once identified further enables the use of a navigation orguidance system to position the distal end 43 b of the catheter tube 43adjacent the target. CT data facilitates the planning of a pathway to anidentified target as well as providing the ability to navigate throughthe body to the target location, this includes a preoperative and anoperative component (i.e., pathway planning and pathway navigation). Asdetailed below, the cytology catheter assembly 12 is guided through thelungs of a patient; however, it is contemplated that the cytologycatheter assembly 12 may be guided through other tubular structures of apatient; e.g., gastro-intestinal tract, lymphatic system, venous,billiary, etc.

The pathway planning phase is generally described below. First, planninga pathway involves using software for generating and viewing athree-dimensional (3D) model of the bronchial airway tree (“BT”) andviewing the CT data to identify targets. Next, the software is used toselect a pathway on the BT, either automatically, semi-automatically, ormanually, if desired. It is to be understood that the airways are beingused herein as an example of a branched luminal network. Hence, the term“BT” is being used in a general sense to represent any such luminalnetwork (e.g., the circulatory system, or the gastro-intestional tract,etc.)

Using a software graphical interface 64 as shown in FIG. 4, generatingand viewing a BT, starts with importing CT scan images of a patient'slungs into the software. The software processes the CT scans andassembles them into a three-dimensional CT volume by arranging the scansin the order they were taken and spacing them apart according to thesetting on the CT when they were taken. The software uses thenewly-constructed CT volume to generate a three-dimensional map, or BT,of the airways. The software then displays a representation of thethree-dimensional map 66 on the software graphical interface 64. A usermay be presented with various views to identify masses or tumors thatthe medical professional would like to biopsy or treat, and to which themedical professional would like to use the cytology sampling system 10to navigate.

Next, the software selects a pathway to a target, e.g., target 68identified by a medical professional. In one embodiment, the softwareincludes an algorithm that does this by beginning at the selected targetand following lumina back to the entry point. The software then selectsa point in the airways nearest the target. The pathway to the target maybe determined using airway diameter. Alternatively, the user rotates thegenerated volume to identify a convenient entry into the luminal networkand the software generates a pathway back to the starting point.

After the pathway has been determined, or concurrently with the pathwaydetermination, the suggested pathway is displayed for user review. Thispathway is the path from the trachea to the target that the software hasdetermined the medical professional is to follow for treating thepatient. This pathway may be accepted, rejected, or altered by themedical professional. Having identified a pathway in the BT connectingthe trachea in a CT image with a target, the pathway is exported for useby cytology sampling system 10 to place a catheter and tools at thetarget for biopsy of the target and eventually treatment if necessary.Additional methods of determining a pathway from CT images are describedin commonly assigned U.S. patent application Ser. No. 13/838,805entitled “Pathway Planning System and Method” the entirety of which isincorporated herein by reference.

FIG. 5 shows a patient “P” lying on an operating table 70 and connectedto a positioning detection system 60 enabling navigation along thedetermined pathway within the luminal network to achieve access to theidentified target. The positioning detection system 60 includes abronchoscope 72, monitoring equipment 74, and a tracking module 80. Thebronchoscope 72 is inserted into the patient's lungs. The bronchoscope72 is connected to the monitoring equipment 74 and the tracking module80, and typically includes a source of illumination and a video imagingsystem. In certain cases, the devices of the present disclosure may beused without a bronchoscope, as will be detailed below. The trackingmodule 80 receives sensor data from a variety of sensors enabling theposition of the patient “P”, the location of the cytology catheterassembly 12, and the image data to be registered to one another therebypermitting navigation of the luminal network using the CT image data andreal-time detection of location. Specifically, tracking module 80utilizes a six DOF (degrees of freedom) electromagnetic positionmeasuring system according to the teachings of U.S. Pat. No. 6,188,355and published PCT Application Nos. WO 00/10456 and WO 01/67035, whichare incorporated herein by reference. An electromagnetic fieldtransmitter 76 is implemented as a board or mat positioned beneathpatient “P.” A plurality of reference sensors 78 are placed on thepatient “P” and their location within the electromagnetic fieldgenerated by the electromagnetic field transmitter 76 can be detected.The location of each sensor 78 is determined in six DOF and their sixcoordinates sent to tracking module 80 and computer 82. One of skill inthe art will recognize that the tracking module 80 may be incorporatedinto computer 82 as a software component and need not be a separatecomponent as depicted in FIG. 5.

FIG. 6 depicts a positioning assembly 84, constructed and operativeaccording to the teachings of the present disclosure. The positioningassembly 84 includes a locatable guide 86 which has a steerable distaltip 88, an extended working channel 90, and, at its proximal end, acontrol handle 92.

There are several methods of steering the locatable guide 86, andtherewith the extended working channel 90. In a first method, a singledirection of deflection may be employed. Alternatively, amulti-directional steering mechanism with a manual direction selectormay be employed to allow selection of a steering direction by thepractitioner without necessitating rotation of the catheter body. Withmulti-directional steering four elongated tensioning elements (“steeringwires”) 98 a are implemented as pairs of wires formed from a single longwire extending from handle 92 to steerable distal tip 88. Steering wires98 a are bent over part of a base 98 b and return to handle 92. Steeringwires 98 a are deployed such that tension on each wire individually willsteer the steerable distal tip 88 towards a predefined lateraldirection. In the case of four steering wires 98 a, the directions arechosen to be opposite directions along two perpendicular axes. In otherwords, the four steering wires 98 a are deployed such that each wire,when actuated alone, causes deflection of the steerable distal tip 88 ina different one of four predefined directions separated substantially bymultiples of 90°.

Locatable guide 86 is inserted into the extended working channel 90within which it is locked in position by a locking mechanism 94. Aposition sensor element 96 is integrated with the steerable distal tip88 of the locatable guide 86 and allows monitoring of the tip positionand orientation (six DOF) as the sensor element 96 traverses theelectromagnetic field generated by the electromagnetic field transmitter76.

In embodiments, extended working channel 90 may have a curved or hookedtip configuration 91 as shown in FIG. 8. This alternative is currentlymarketed by Covidien LP under the name EDGE®. Differing amounts ofpre-curve implemented in the extended working channel 90 can be used,however, common curvatures include 45, 90, and 180 degrees. The 180degree extending working channel 90 has been found particular useful fordirecting the locatable guide 86 to posterior portions of the upper lobeof the lung which can be particularly difficult to navigate. Thelocatable guide 86 is inserted into the extended working channel 90 suchthat the position sensor 96 projects from the extended working channel90. The extended working channel 90 and the locatable guide 86 arelocked together such that they are advanced together into the lungpassages of the patient “P.” Optionally, the locatable guide 86 or theextended working channel 90 may include a steering mechanism similar tothe one described above. As can be appreciated, certain modificationsmay need to be made to the extended working channel 90 in order for theextended working channel to function as intended.

In embodiments, an integrated radial ultrasound probe “US” (FIG. 8) maybe provided on the extended working channel 90, the locatable guide 86,and/or the cytology catheter assembly 12. For illustrative purposes, theultrasound probe “US” is shown disposed on the extended working channel90 and the locatable guide 86. The ultrasound probe “US” may beconfigured to provide ultrasound feedback to one or more modules of thecytology sampling system 10 during navigation and insertion of thecytology tool 14 to facilitate positioning the distal end 43 b of thecatheter tube 43 adjacent target tissue. As will be appreciated a USprobe may also be used without the extended working channel but inconjunction with an endoscope for imaging central lesions that would beaccessible to the endoscope. Furthermore, the US probe may be used toconduct ultrasound interrogation of tissue. Alternatively, fluoroscopyor other imaging modalities may be used to confirm the placement of thelocatable guide and therewith the extended working channel 90 and thebrush 44.

As noted above, the present disclosure employs CT data (images) for theroute planning phase. CT data is also used for the navigation phase.Specifically, the CT system of coordinates is matched with the collectedsensor data; this is commonly known as registration. Manual,semi-automatic, or automatic registration can be utilized with thecytology sampling system 10. For purposes herein, the cytology samplingsystem 10 is described in terms of use with automatic registration.Reference is made to commonly assigned U.S. Patent Pub. No.2011/0085720, which is incorporated herein by reference, for a moredetailed description of automatic registration techniques.

The automatic registration method includes moving locatable guide 86containing position sensor 96 within a branched structure of a patient“P.” Data pertaining to locations of the position sensor 96 with respectto the electromagnetic filed generated by the electromagnetic fieldtransmitter 76 is recorded. A shape resulting from the data is comparedto an interior geometry of passages of the three-dimensional model ofthe branched structure. And, a location correlation between the shapeand the three-dimensional model based on the comparison is determined.

In addition to the foregoing, the software of the cytology samplingsystem 10 identifies non-tissue space (e.g., air filled cavities) in thethree-dimensional model. Thereafter, the software records position dataof the position sensor 96 of the locatable guide 86 as the locatableguide 86 is moved through one or more lumens of the branched structure.Further, the software aligns an image representing a location of thelocatable guide 86 with an image of the three-dimensional model based onthe recorded position data and an assumption that the locatable guide 86remains located in non-tissue space in the branched structure.

Once in place in the patient “P,” a screen 93 will be displayed by thesoftware on the monitoring equipment 74 (FIG. 9). The right image is anactual bronchoscopic image 95 generated by the bronchoscope 72.Initially there is no image displayed in the left image 97, this will bea virtual bronchoscopy generated from the CT image data onceregistration is complete.

Starting with the locatable guide 86, and specifically the positionsensor 96 approximately 3-4 cm above the main carina, as viewed throughthe bronchoscope 72, the bronchoscope 72 is advanced into both the rightand left lungs to, for example, the fourth generation of the lungpassages. By traversing these segments of the lungs, sufficient data iscollected as described above such that registration can be accomplished.

Now that the targets have been identified, the pathway planned, thebronchoscope 72 including locatable guide 86 inserted into the patient“P,” and the virtual bronchoscopy image registered with the image dataof the bronchoscope 72, the cytology sampling system 10 is ready tonavigate the position sensor 96 to the target 68 within the patient'slungs. The computer 82 (FIG. 5) provides a display for identifying thetarget 68 and depicting the virtual bronchoscopy image 99. Appearing ineach of the images on the display is the pathway from the currentlocation of the position sensor 96 to the target 68. This is the pathwaythat was established during the pathway planning phase discussed above.The pathway may be represented, for example, by a colored line. Alsoappearing in each image is a representation of the steerable distal tip88 of the locatable guide 86 and position sensor 96. Once the steerabledistal tip 88 traverses the established pathway, a clinician may utilizethe cytology catheter assembly 12 to sample the target tissue 68 asdetailed below.

Operation of the cytology catheter assembly 12 with the positioningassembly 84 to sample target tissue is described with reference to FIGS.10A-11B. Once the locatable guide 86 or an additional access tool hassuccessfully been navigated to the target 68 location, the locatableguide 86 or access tool may be removed, leaving the extended workingchannel 90 in place as a guide channel for the cytology catheterassembly 12 (FIG. 1) to the target 68 location (FIGS. 11A-11B).

In some cases the target may be directly accessed from within the lumen(such as for the sampling of the endobronchial wall), however in otherinstances, the target is not within the BT and use of the locatableguide alone does not achieve access to the target. Additional accesstools may be required to cross the lumen wall and access the target(such as for the sampling of disease within the parenchyma).

Final localization and confirmation of the locatable guide or accesstool with extended working channel may be performed with imaging and/ornavigational guidance (this may include the same or differentcombinations of imaging and navigation techniques listed above).

The catheter tube 43 is inserted through the working channel 90 suchthat the distal end 43 b of the catheter tube 43 is adjacent the target68. Alternatively, the catheter tube 43 or the cytology tool 14 mayitself include a position sensor 88, such that the catheter tube 43 isalready inserted through the working channel 90 during the positioningof extended working channel. The position sensor 88 may also be disposedon the distal end 43 b of the catheter tube 43 or on the brush 44. Thecytology tool 14 is inserted through the catheter tube 43 as detailedabove to collect cell samples from the target 68. It is alsocontemplated that the cytology tool 14 may be inserted directly throughworking channel 90 without a catheter tube 43.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Any combination ofthe above embodiments is also envisioned and is within the scope of theappended claims. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of particularembodiments. Those skilled in the art will envision other modificationswithin the scope and spirit of the claims appended hereto.

1-20. (canceled)
 21. A cytology tool for placement within an airway of apatient's lung, comprising: a flexible catheter tube defining alongitudinal axis; a handle disposed at the proximal end of the flexiblecatheter tube; a plurality of flexible brush shafts biased away from thelongitudinal axis and coupled to the handle, wherein the handle isconfigured to move relative to the flexible catheter tube to transitionthe plurality of flexible brush shafts between a first position whereinthe plurality of flexible brush shafts is disposed within a lumendefined by the flexible catheter tube such that the plurality offlexible brush shafts is urged into substantial alignment with thelongitudinal axis, and a second position wherein the plurality offlexible brush shafts is deployed from a distal end of the flexiblecatheter tube and radially spaced from the longitudinal axis, eachflexible brush shaft of the plurality of flexible brush shafts forming aneedle tip at a distal end thereof; and a plurality of nylon bristlesdisposed helically around each flexible brush shaft of the plurality offlexible brush shafts, the plurality of bristles extending radially awayfrom an outer surface of each flexible brush shaft of the plurality offlexible brush shafts, the needle tip of each flexible brush shaft ofthe plurality of flexible brush shafts configured to penetrate a wall ofan airway of a patient's lung for contacting target tissue with theplurality of nylon bristles to capture cells from the target tissue viathe bristles.
 22. The cytology tool according to claim 21, wherein theplurality of flexible brush shafts includes three flexible brush shafts.23. The cytology tool according to claim 21, wherein the plurality ofnylon bristles is disposed helically around the entire length of eachflexible brush shaft of the plurality of flexible brush shafts.
 24. Thecytology tool according to claim 21, wherein the outer diameter of theflexible catheter tube is in a range of about 1.5 mm to about 2.5 mm.25. The cytology tool according to claim 21, wherein the outer diameterof the flexible catheter tube is about 1.92 mm.
 26. The cytology toolaccording to claim 21, wherein the length of the flexible catheter tubeis in a range of about 60 cm to about 180 cm.
 27. The cytology toolaccording to claim 21, wherein the length of the flexible catheter tubeis about 120 cm.
 28. The cytology tool according to claim 21, whereinthe length of each flexible brush shaft of the plurality of flexiblebrush shafts is in a range of about 10 mm to about 25 mm.
 29. Thecytology tool according to claim 21, wherein the length of each flexiblebrush shaft of the plurality of flexible brush shafts is about 15 mm.30. The cytology tool according to claim 21, wherein the length of eachflexible brush shaft of the plurality of flexible brush shafts is lessthan 10 mm.
 31. The cytology tool according to claim 21, wherein thelength of each flexible brush shaft of the plurality of flexible brushshafts is greater than 25 mm.
 32. The cytology tool according to claim21, wherein the outer diameter of each flexible brush shaft of theplurality of flexible brush shafts is in a range of about 0.5 mm toabout 1.0 mm.
 33. The cytology tool according to claim 21, wherein theouter diameter of each flexible brush shaft of the plurality of flexiblebrush shafts is about 0.75 mm.
 34. The cytology tool according to claim21, wherein the plurality of nylon bristles extend radially away fromthe outer surface of each flexible brush shaft of the plurality offlexible brush shafts a distance in a range of about 0.25 mm to about1.0 mm.
 35. The cytology tool according to claim 21, wherein theplurality of nylon bristles extend radially away from the outer surfaceof each flexible brush shaft of the plurality of flexible brush shafts adistance of about 0.85 mm.
 36. A cytology tool for placement within anairway of a patient's lung, comprising: a flexible catheter tubedefining a longitudinal axis; a plurality of flexible brush shaftsbiased away from the longitudinal axis, the plurality of flexible brushshafts movable along the longitudinal axis between a first positionwherein the plurality of flexible brush shafts is disposed within alumen defined by the flexible catheter tube such that the plurality offlexible brush shafts is urged into substantial alignment with thelongitudinal axis, and a second position wherein the plurality offlexible brush shafts is deployed from a distal end of the flexiblecatheter tube and radially spaced from the longitudinal axis, eachflexible brush shaft of the plurality of flexible brush shafts forming aneedle tip at a distal end thereof; and a plurality of nylon bristlesdisposed helically around each flexible brush shaft of the plurality offlexible brush shafts, the plurality of bristles extending radially awayfrom an outer surface of each flexible brush shaft of the plurality offlexible brush shafts, the needle tip of each flexible brush shaft ofthe plurality of flexible brush shafts configured to penetrate a wall ofan airway of a patient's lung for contacting target tissue with theplurality of nylon bristles to capture cells from the target tissue viathe bristles.
 37. The cytology tool according to claim 36, wherein theplurality of flexible brush shafts includes three flexible brush shafts.38. The cytology tool according to claim 36, wherein the plurality ofnylon bristles is disposed helically around the entire length of eachflexible brush shaft of the plurality of flexible brush shafts.
 39. Thecytology tool according to claim 36, wherein the length of each flexiblebrush shaft of the plurality of flexible brush shafts is in a range ofabout 10 mm to about 25 mm.
 40. A cytology tool for placement within anairway of a patient's lung, comprising: a first flexible brush shaft anda second flexible brush shaft movable along a longitudinal axis betweena first position wherein the first and second flexible brush shafts areurged into substantial alignment with the longitudinal axis and a secondposition wherein the first and second flexible brush shafts are radiallyspaced from the longitudinal axis, each of the first and second flexiblebrush shafts forming a needle tip at a distal end thereof, wherein thelength of each of the first and second flexible brush shafts is in arange of about 10 mm to about 25 mm; and a plurality of nylon bristlesdisposed helically around each of the first and second flexible brushshafts, the plurality of bristles extending radially away from an outersurface of each of the first and second flexible brush shafts a distancein a range of about 0.25 mm to about 1.0 mm.